drugset / Trial / NCT01912495
Dutch Acute HCV in HIV Study (DAHHS)
Phase 2
Completed
65 enrolled
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabMaastricht University Medical Center · collabOnze Lieve Vrouwe Gasthuis · collabRadboud University Medical Center · collabRijnstate Hospital · collabSlotervaart Hospital · collabUMC Utrecht · collabUniversity Medical Center Groningen · collab
NaSingle-groupOpen-labelTreatment
Summary
Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4. The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
Timeline
- Start
- 2013-08
- Primary completion
- 2015-08
- Completion
- 2016-01
Publications
- Popping S, Cuypers L, Claassen MAA, van den Berk GE, De Weggheleire A, Arends JE, Boerekamps A, Molenkamp R, Koopmans MPG, Verbon A, Boucher CAB, Rijnders B, van de Vijver DAMC. Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals. Viruses. 2022 Sep 2;14(9):1953. doi: 10.3390/v14091953.
- Hullegie SJ, Claassen MA, van den Berk GE, van der Meer JT, Posthouwer D, Lauw FN, Leyten EM, Koopmans PP, Richter C, van Eeden A, Bierman WF, Newsum AM, Arends JE, Rijnders BJ. Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients. J Hepatol. 2016 Apr;64(4):807-12. doi: 10.1016/j.jhep.2015.12.004. Epub 2015 Dec 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Boceprevir | Small molecule | — | — |